Dose counter and recording method

ABSTRACT

A dose counter for a metered dose inhaler includes a force sensor, an electronic controller, a memory for storing data indicative of a remaining number of doses and an electronic display device coupled to the controller for displaying the remaining number of doses. The dose counter is attached or integrated into a base of a canister containing medicament such that force applied to the base of the canister is registered by the force sensor, the controller being configured to measure force applied to the dose counter when depressing the canister and being responsive to measured force to decrement the remaining number of doses stored in the memory and shown on the display device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application No.12/855,685, filed Aug. 12, 2010, which claims priority to U.S.Provisional Patent Application No. 61/234,657, filed Aug. 18, 2009, bothof which are incorporated herein by reference in their entirety for allpurposes.

FIELD OF THE INVENTION

The present invention is in the field of dose counters for metered doseinhalers (MDIs). There is a regulatory requirement to either display thenumber of doses remaining within the device or show whether the spraycanister is exhausted, and the present invention provides an electronicdose counter which supplies such an indication in a simple manner.

BACKGROUND OF THE INVENTION

The idea of having a dose counter is well known in the art, and a numberof potential implementations for such a counter exist. U.S. Pat. No.5,363,842 describes an inhaler which detects how much air is inhaledthrough it and during what course of time, including such measurementsas the triggering of the release of aerosol, and also incorporates adose counter.

U.S. Pat. No. 5,411,173 describes a counter device attachment for adepressible spray dispenser for products such as medicine. The dispensercomprises a clip to fit about the side wall of the dispenser's casing, afoot-leg positioned beneath the dispenser and connected to the clip, anda counter actuated by the shaft which moves within a shaft housing,wherein a button on the counter is incremented each time the tank isdepressed.

U.S. Pat. No. 5,482,030 describes a counter for a spray containerimplementing a counting disk showing the number of activations. U.S.Pat. No. 5,544,647 and U.S. Pat. No. 5,622,163 describe an electroniccounting device mounted on the exterior of the housing, which indicatesthe number of doses remaining in the canister as signaled by a switchactivated by the canister movement.

U.S. Pat. No. 5,505,192 describes an electronic dispenser monitoringcircuit mounted on the canister, comprising an elastomeric membraneswitch which serves to count the number of doses given. U.S. Pat. No.5,676,129 describes a dose counter based on the use of a miniaturepressure sensor which detects the pressure pulse in the transfer channelof the mouthpiece of the MDI through which the inhaler dose is released.U.S. Pat. No. 5,809,997 describes a dose counter attached to the inhalerhousing incorporating a strain gauge sensing extending through a hole ina side of the housing for engaging a portion of the canister next to thevalve stem. The sensing arm senses when the valve stem of the canisteris properly compressed for release of medication.

U.S. Pat. No. 6,029,659 describes an inhaler inside a housing of which adose counter is activated by a push button that is depressed when forceis applied to the canister. U.S. Pat. No. 6,138,669 describes the use ofa miniature pressure sensor and microprocessor to detect the pressurepulse in the transfer channel of the mouthpiece of the MDI through whichthe inhaler dose is released. U.S. Pat. No. 6,283,365 describes a dosecounter attached or attachable to the base of the canister, comprising aspring-loaded cap which is depressed in relation to a second partmounted on the domed base of the canister. Within the cap is a pair ofindependently rotatable rings, where each depression of the cap relativeto the canister, causes the first ring to rotate and thus implement amechanical counter. U.S. Pat. No. 6,405,727 describes a dose countingmechanism based on a wheel with a toothed disc portion and a smoothdisc, the smooth disc of the wheel bearing digits 00 to 20 and the wheelbearing digits 0 to 9. When the wheels are viewed the display can showany number from 000 to 209.

U.S. Pat. No. 6,431,168 describes a mechanical, cog-based, doseindicator located within the base of the inhaler housing, by the outletof the canister. U.S. Pat. No. 6,446,627 describes a dose indicatorbased on a rotary gear which moves in step-wise fashion in response todisplacement of an actuator, where the rotary gear comprises a wheelhaving a plurality of ratchet teeth. U.S. Pat. No. 6,659,307 describes adose counter comprising at least one flexible rotary counting elementapplied against and turning on a curved support surface.

U.S. Pat. No. 6,761,161 describes a dose counter comprising a ratchetwheel, a drive member selectively engaging the indicating member, a pawlselectively engaging the ratchet wheel, and a non-return member adaptedto selectively engage the ratchet wheel so as to maintain aunidirectional rotation of the ratchet wheel. In one embodiment, theindicating device also includes a usage indicator member having usageindicia that indicates the number of usage cycles completed or remainingfor the indicating device.

U.S. Pat. No. 7,331,340 describes an inhaler for use with a removablepressurized aerosol canister, having a display for indicating to a userthe state of the canister. A memory device on the canister (or a housingwhich houses the canister) stores information indicative of dosesdispensed from, or remaining in, the canister, where that information isprocessed to provide and display information representative of the stateof the canister. US 20040255936 describes a disposable dose counter. US20060254581 describes a counter module affixed to a MDI canister, and isthus differentiated from an embodiment in which the counter is affixedor built into an actuator body. The visual display is read from abovethe inhaler, or from a direction that is generally radial with respectto the major axis of the inhaler. Relative motion of the canister withinthe actuator body activates a switch component of the EDC module bymeans of a trigger mechanism positioned within a cap that is fixedlymounted to the canister.

US 20070295329 also describes an electronic counter module mounted onthe base of the canister, where depression of the top of this modulecloses two contacts separated by a spring. The spring ensures thatsufficient force is developed before the counter is incremented. US20080017193 describes a dose counter comprising a sensor for directlydetecting a metered medicament dose dispensed from said containerthrough its outlet, and a visual display unit for displaying the numberof metered doses of medicament used or remaining within the container.

U.S. Pat. No. 7,587,988 describes a mechanical dose indicator comprisinga counter housing, a rocker arm with a pawl, the rocker arm beingpivotally supported by the housing and arranged to perform a rockermovement in response to a linear actuation motion, a return spring forresetting the rocker arm, a ratchet wheel engageable with the pawl toconvert the movement of the rocker arm into an incremental rotationalmotion of an axle arrangement, thus advancing a display means.

US 20080066742 describes a mechanical counting mechanism where thedisplay arrangement is of pointer-gauge type with a static displaysection provided as an integrated part of a transparent displaycontaining part of a counter housing. U.S. Pat. No. 7,637,227 describesa inhaler device counter for displaying remaining doses of medicinehaving a pointer gauge type display, integrally formed with the counterhousing. US 2009139516 describes a dose counter for an inhaler having acount wheel with fixed index tooth arranged for intermittent meshingwith kick teeth, such that rotation of a kick wheel results fromrotation of the count wheel when intermittent meshing occurs.

Thus the prior art is broadly divided into (a) mechanical solutions withsome kind of dial which is advanced mechanically after each depressionof the canister, and (b) electronic devices showing the number of dosesremaining on an LCD or such like. The electronic type of dose counter isfurther divided into those which sense the aerosol dose being released(for example using a pressure sensor located adjacent to the aerosoloutlet), and those based on a switch which is actuated upon the physicaldepression of the canister. In the latter type, the travel or physicalmovement between the open and the closed position of the switch takesplace either between the canister and its housing (i.e. the inhaler) orbetween two parts of a module attached to the canister. In either case,it is the physical travel associated with the physical depression of thecanister which closes the switch and thus increments the dose counter.As with any dose counter that is not actually verifying the release ofthe dose but is merely based on the travel detected, there is apossibility of false positives or false negatives.

SUMMARY OF THE INVENTION

An objective of the present invention is to provide an electronic dosecounter which is not based on travel and is therefore less subject topotential mechanical errors than some prior art embodiments. Furtherobjects of the present invention include reduction of potential falsepositives (where the counter is decremented but the dose is notdelivered) and false negatives (where the dose is delivered but thecounter is not decremented).

A further objective of the invention is to provide a method for using anelectronic dose counter for recording, downloading and analyzing thedosing history from one or more MDIs. Such a method may be used toenable a medical practitioner to evaluate the compliance of the patientwith a medication regimen.

A still further object of the invention is to provide a method oftreatment whereby the prescribing information of the relevant MDI drugrecommends that the medication regimen should not be changed without themedical practitioner first evaluating the patient's compliance history.

These objectives are realized in accordance with an aspect of theinvention by a dose indicator comprising a force or pressure sensor andan electronic controller; said dose indicator being attached to the baseof canister of a metered dose inhaler (MDI) in order to detect theactivation action of said MDI. As the patient applies pressure to thecanister in order to press the canister into the inhaler device, thesensor detects that pressure has been applied to the base of thecanister. Data are collected by an electronic controller that processesthe input from this sensor and includes the pressure gradients andduration. Given that the canister has a known firing pattern in terms ofpressure gradient and duration, the controller can implement analgorithm that can be set to decrement the dose counter only when thepressure profile detected closely matches the profile required to “fire”the canister in order to deliver the dose. Advantageously, this ensuresthat the potential for false positives and false negatives registered bythe dose counter of the present invention is minimized. Advantageously,the approach of the present invention also obviates the need to providesome kind of mechanical travel arrangement within or associated with thedose counter, thereby reducing the potential for mechanical failure. Insome embodiments, the dose counter is a miniature module, which isattached to the base of the canister and which contains all the elementsrequired to implement the functionality of the dose counter—i.e. thepressure sensor, the controller, digital display and battery—in a thin,low-profile, module or sticker.

Furthermore, the addition of an electronic dose counter (whether such asthat provided above or otherwise implemented) enables the implementationof a method of recording and downloading the history of the doses taken,and associating this history with a specific day and time. The inventionprovides a method of performing such recording and associatedcommunications mechanisms for associating the dosing history with aspecific date and time.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carriedout in practice, embodiments will now be described, by way ofnon-limiting example only, with reference to the accompanying drawings,in which:

FIG. 1A provides a cut-away cross-sectional view showing the location ofthe dose counter on the canister and inhaler arrangement;

FIG. 1B shows a planar view of a preferred embodiment of the dosecounter;

FIG. 2A shows an exploded diagram of a preferred embodiment of the dosecounter, implemented as a multi-layer “sandwich”, and FIG. 2B shows aperspective view of the dose counter;

FIGS. 3A and 3B show relationships between the force/duration patterndetected by the force sensor and the firing of the dose;

FIG. 4 shows a block diagram of the dose counter and

FIG. 5 provides an example of a medical practitioner's screen-shotshowing the integrated dosage history from two MDI devices, each fordelivering a different drug.

DETAILED DESCRIPTION OF EMBODIMENTS

The operating principle of the dose counter is that it is able tocapture data from its force sensor component in order to determine witha high degree of accuracy whether a dose has been administered from anMDI. Referring now to FIG. 1A, the overall configuration of a typicalMDI is shown, showing a housing 10, a canister 12 and a dose counter 14mounted on, adhered to or otherwise affixed to the base of the canister12. When a patient presses the base of the canister 12 in order toadminister a dose of aerosol from the MDI, the pressure applied to thebase of the canister 12 can be measured and thereby serve an input tothe dose counter.

Referring now to FIG. 1B, an embodiment of the dose counter 14 is shown,illustrating surface features including a liquid crystal display (LCD)16 capable of displaying the number of doses remaining and one or moreinformative icons. The LCD preferably displays at least three digits, asmany available MDIs in excess of 100 doses. The display may beconfigured to display the number of remaining doses (say 123 as shown),which is decremented each time the appropriate depression is performedby the patient. In the event that the first few depressions serve toprime the MDI, then the display may contain an alphanumeric display suchas “PRM” until these first few depressions have been given. The optionalinclusion into the LCD 16 of further icons (not shown) can serve toprovide a non-numeric indication of the state of the inhaler, forexample flashing when the inhaler is within the last few doses of beingempty.

Further functions that the dose counter 14 can incorporate include:

-   -   An indication that the next dose is due to be taken. In this        case a further icon can flash to indicate readiness. For        example, if the dose is taken twice a day, then this icon can be        activated 10 hours after each dose and thus, when the patient        looks at the device, he knows whether he is supposed to take the        next dose. This is particularly useful if the patient takes the        dose and then forgets that he has done so. When he sees that        this icon is not flashing, he will know that he already took the        dose.    -   A connector 19 enabling an external device such a PC to be        connected to the canister, enabling the external device to        download the history of doses given (and their time intervals)        for viewing by the medical practitioner. This provides the        medical practitioner with a way to examine how well the patient        has been compliant with the prescribed regimen.    -   An audible and or audio-visual alarm when a scheduled dose has        been missed.

In some embodiments of the dose counter of the present invention, thecounter is fabricated as a multi-layer “sandwich” type assemblage inorder to simplify construction and minimize component costs. Referringnow to FIGS. 2A and 2B, a possible layout for this assembly is provided,showing an at least partially transparent top layer 20, covering acircuit board comprising the LCD 16, a microcontroller 26, and a quartzoscillator 27 for stabilizing the time recording. The controller 26 isfurther connected to a force or pressure sensor such as a forcesensitive resistor (FSR) 22, preferably printed or mounted on a separatelayer of the sandwich as shown. An FSR is typically made of aproprietary polymer thick film ink screen printed on various substratessuch that as force is applied to the device, the electrical resistancedecreases. Such FSRs are available from Sensitronics LLC of 16120 ParkPlace, Bow, Wash. 98232, USA. Lastly, a base cover 29 serves to connectthe dose counter to the canister, whether by adhesion, snap fit or anyother mechanical attachment mechanism known in the art. The power forthe dose controller is provided by a miniature battery 28 which may belocated at least partially within a depression in the base cover 29,such that the space in the depression on the bottom of a canister can beexploited.

The layers of the dose counter may be arranged (and any internal spacesfilled in) such that the dose counter constitutes a largely solidintegral object which conveys the force applied on its top surface(which is the transparent layer 20 in the preferred embodiment shown) tothe force sensor 22. A number of potential force or pressure sensortechnologies may be used in the present invention, including but notlimited to pressure sensitive resistors (FSRs), piezoelectric sensors,strain gauges, and MEMS-based sensing technologies for measuring strainand capacitance. Preferably, the force sensitive resistor extends overmost of the surface area of the appropriate layer within the doseindicator, as shown in this figure.

Advantageously, the use of an electronic module (as opposed to amechanical counter) enables the measurement not just of the actionperformed but also of the duration of this action. Thus, whereas amechanical mechanism can show displacement, it is typically unable toshow whether the displacement were maintained for sufficient time toensure delivery of the dose. However, an electronic dose counter such asthat of the present invention is capable of monitoring not only theaction performed but also its duration. Referring now to FIG. 3A, atypical force vs. time curve is shown, illustrating the gradual increasein force as the base of the canister is depressed. This force reachesits peak as the canister reaches the limit of its travel and issues thedose. By setting the parameters of the electronic controller of the dosecounter of the present invention such that, in a preferred embodiment,the dose counter decrements the counter only when the force exceeds adefined threshold (shown as Y) for a defined minimum duration (shown asX), the dose counter exhibits a very low level of false positives andnegatives.

In order to achieve an accurate determination of when an actuation hastaken place it is important to understand that the interpretation of theforce applied requires a software component, and thus an electroniccontroller, for a number of reasons. For example, the activation forceof the canister typically decreases over the number of actuations owingto aging, such that the force required for the initial actuations issignificantly altered during the use of the product. For example,typical figures for “force to fire” are around 18N-20N at the start ofuse, gradually declining, roughly linearly, to around 15-17N as the MDIapproaches the last dose (after say 120 doses). Thus, in this example,the threshold set in the software of the dose counter can for instancestart at just above 18N, and then decline linearly to starting justabove 15N; in order to minimize the number of false positives. The dosecounter of the present invention includes a software component capableof implementing such an algorithm, which of course cannot be done usinga fixed spring to determine the force applied as is done by somehitherto-proposed solutions. Furthermore, the controller of the presentinvention also measures the duration of the depression, so that the dosecounter cannot be triggered by the device for example falling to theground and receiving a knock on the base of the canister.

As shown in FIG. 3B, a further level of resolution may be achieved byanalyzing the pattern of the increase in force in order to establishthat the dose has been given. It is seen in FIG. 3B that there are threedistinct zones: (A) The reaction of the canister valve spring preloadforce, where the slope represents the elasticity of the finger muscles;(B) The reaction force related to the valve's spring constant plus anadditional drag force induced by gas flow around the valve plunger; and(C) The reaction force as the valve reaches its stop position whereagain the slope is related to the finger muscles elasticity. In boththese embodiments, the monitoring of the force buildup (and release)over time enables a simpler method of accurately determining whether adose has been given than alternative mechanical approaches.

FIG. 4 is a block diagram showing the functionality of the dose counter.A microcontroller unit (MCU) interfaces with the analog circuitry andforce sensor, and enables communications with an external cradle fordata transfer via a communication interface. Note that by furthercomprising a time-measurement component, such as watch-type quartzoscillator shown in FIG. 2B, the time-measurement can be stabilized.Furthermore, the provision of sufficient memory within the dose counterdevice enables the history of the doses taken over time to be recorded.This history recording enables subsequent downloading of this history bymedical personnel. The downloading may be performed via either aphysical connection means such as the connector 19 shown in FIG. 1 orvia a contactless interface means such as induction or wireless, to anexternal computer (such as the medical practitioner's PC), for displayand/or analysis and/or storage.

The addition of an electronic dose counter (whether such as thatprovided above or otherwise implemented) enables the implementation of amethod of recording and downloading the history of the doses taken, andassociating this history with a specific day and time. Possible methodsfor associating the dosing history with a specific date and time includethe following:

-   -   1) In one embodiment, the dose counter has its internal clock        set at time of manufacture, assembly or distribution, so that        the actual time and date of taking each dose can be recorded. As        the dose counter may be used in different countries, it is        simplest to set the date and time at manufacture or assembly        according to a standard such as GMT. By providing a function in        the medical practitioner's software to define the offset between        the local date-time and GMT, the local date and time of each        dose may be displayed on the medical practitioner's computer.    -   2) Alternatively, the dose counter stores relative time and/or        time intervals between doses rather than absolute time.        Advantageously, this obviates the need to have the internal        clock set to a specific time. According to one embodiment of        this method, the first dose marks the starting point (T.sub.1=0)        of recording a relative-time index, where the dose counter        accumulates the time in minutes thereafter. The next dose may        take place after 4 hours and would therefore be time-stamped as        occurring at T.sub.2=240, etc. When the dose counter is        interfaced to the medical practitioner's computer, the actual        time as either stored on that computer (or downloaded from a        central time server such as NTP) is then used to assign the        actual times to the dose timestamps. For example if at that        point the internal timer in the above example shows 480 minutes        since the starting point and the current time is 4 pm, then the        first dose took place 480 minutes (i.e. 8 hours) ago, and        therefore that dose can be shown as having taken place at 8 am        that same day, with the second dose having been taken at 12        noon. This mapping of the relative times stored in the dose        counter's memory, to actual local time can take place each time        that dosage information is downloaded. Alternatively, the        downloading process can involve resetting the relative time        setting in the dose counter to an absolute time, so that the        dose counter then goes over to a mode of time-stamping the doses        in terms of the actual time.

Although the above examples describe the communication as taking placethough a wired connection to the medical practitioner's computer, theseare just examples and the scope of the method should be understood toencompass any type of communication between a dose counter and anexternal computer, whether wired or wireless, and any kind of remotedisplaying or analyzing device whether a hand-held computer or a centralhealth-system one. Thus the dose counter history could be uploadedwirelessly from a Bluetooth.™./WiFi-enabled cradle to a remote computervia the cellular network. Likewise the display and or analysis devicecan be a hand-held computer or smart phone, which can optionally serveto store the dosing history.

The dose recording and downloading method of the present invention alsoprovides the functionality to make use of time-stamped dose historyuploaded by an electronic dose counter to an external host system, suchas a doctor's computer, for more extensive analysis. Such functionalitycan include integrating the uploaded history over time, whereby datafrom both the current inhaler device and previous ones are displayed intabulated or graphical form along a common time axis. Advantageously, assome patients have two or more different types of inhaler, thisfunctionality enables data relating to the presentation and/or analysisof the history of use of multiple inhalers (of all types) used by thepatient to be superimposed. This can give a clear picture of thepatient's medical history, for example how often he has used a rescueinhaler and at what times of the day.

As is standard on MDIs and many other drug products, the prescribinginformation provides dosing information and/or other instructions. Inthe specific case of an MDI with a dose counter which stores the dosinghistory (as per the current invention), this prescribing information canadditionally perform the role of conveying a recommendation to themedical practitioner. Such recommendation may be not to change amedication regimen until the patient's dosing history has been evaluatedfor compliance with the intended regimen. For example, the medicalpractitioner may believe that, as the patient is apparently notresponding to (or properly “controlled” by) the medication, the patientshould be given a more potent drug. However, the purpose of therecommendation on the prescribing information is to ensure that themedical practitioner does not make this determination without firstreviewing the patient's actual compliance history. If, on review of thedosing history, it transpires that the patient has not been taking thedrug as required, then the medical practitioner should take this factinto account. This method of treating a patient increases the likelihoodthat a patient will not be prescribed a new medication regimen unless aprevious regimen—with which he was verified to be compliant—is shown tobe ineffective.

Typical MDI drugs for asthma include both controller and relievermedications. Controllers such as an inhaled corticosteroid serve toreduce the likelihood of having an asthma attack. Reliever drugs, suchas Beta2-antagonists, on the other hand, serve to respond to an asthmaattack when it occurs. The use of a dose counter having downloadcapability on both types of inhaler enables the medical practitioner toshow the dosage history from both MDIs in a unified picture asillustrated in FIG. 5. This provides the medical practitioner with aclear picture of whether the patient is “controlled” with his existingmedication, or uncontrolled; and also whether the lack of control wasdue to the patient failing to take his medication as prescribed. In thisway, a method of treatment can be implemented whereby the prescribinginformation for the MDI recommends to the medical practitioner to checkthe dosage history of the patient—across one or more drug types—beforemaking any changes to the patient's medication.

In one embodiment, the dose history may be stored as an Internet-basedapplication. In this embodiment, the dosing history is stored on a webserver and the patient and the medical practitioner can view thishistory through their computers, preferably by viewing the appropriateweb application through a browser.

In order to minimize the power consumption of the dose controller, apush button as shown in the block diagram may be activated by theinitial force applied to the upper surface 20 of the dose counter, suchthat that the circuit is then activated and the change of force appliedover time monitored by the microcontroller unit (MCU) thus awakened. Tothis end it is preferable to use a microcontroller which can bere-activated very quickly, such as the MSP430F4132IPM microcontrollerfrom Texas Instruments. Advantageously, this enables the limited powersupply supplied by a small battery to maintain both the timekeepingfunction and the time-stamping of the dose recording to work over a longtime period extending as far as a few years. This is desirable as theinhalers may have a long shelf-life, followed by a year or two ofoccasional use.

In conclusion, the invention provides a dose counter based onintegrating an electronic module into the base of an MDI canister, thedose counter being capable of measuring the number of doses deliveredand displaying the number of doses delivered or remaining via anelectronic display means. The dose counter uses a force sensor to detectthe action of depressing the canister into the MDI housing in order todeliver the dose, and thus does not depend on the measurement ofphysical travel. Also described is a method for recording anddownloading the dosing history. Although some preferred embodiments havebeen described, the invention is not limited to the specific embodimentsas described and is limited only the scope of the appended claims.

What is claimed:
 1. A method for facilitating monitoring by a medicalpractitioner of adherence by a patient to a medication regimen requiringadministering to the patient at least two drugs using more than a singlemetered dose inhaler, said method comprising: recording in a memory ofeach inhaler dosage data indicative of actual dosage including for eachdose administered to the patient a time-stamp permitting determinationby the medical practitioner of an actual time; coupling each of themetered dose inhalers to a computer of the medical practitioner fordownloading said dosage data to said computer; presenting the respectivedosage data from each of the inhalers in a form that allows a unifiedpicture thereof; and associating with the metered dose inhaler arecommendation to the medical practitioner to verify compliance by thepatient to an existing metered dose inhaler medication regimen prior toprescribing a different medication regimen.
 2. The method according toclaim 1, wherein presenting the respective dosage data includesdisplaying the data graphically on a common time axis.
 3. The method ofclaim 1 wherein coupling the metered dose inhaler to a computer includescoupling via an IP network.
 4. The method of claim 3, wherein the IPnetwork is the Internet,
 5. The method according to claim 1, whereinassociating said recommendation with the metered dose inhaler includesadding to the metered dose inhaler package instructions bearing saidrecommendation.
 6. A method for minimizing risk of a medicalpractitioner prescribing a change of drug treatment administered via ametered dose inhaler to a patient whose poor response to an existingmedication regimen is due to his or her non-compliance with a currentmedication regimen, said method comprising: coupling a memory of themetered dose inhaler to a computer for downloading dosage data stored insaid memory to computer, said dosage data being indicative of actualdosage administered to the patient including for each dose administeredto the patient a time-stamp permitting determination by the medicalpractitioner of an actual time adjusted to a local time reference;determining from the dosage data whether the patient has complied with acurrent medication regimen by comparing the dosage data with the currentmedication regimen; and associating with the metered dose inhaler arecommendation to the medical practitioner to verify compliance by thepatient to an existing metered dose inhaler medication regimen prior toprescribing a different medication regimen.
 7. A metered dose inhaler(MDI) comprising: a canister and a memory for storing dosage dataindicative of actual dosage administered to the patient including foreach dose administered to the patient a time-stamp permittingdetermination by the medical practitioner of an actual time adjusted toa local time reference, and prescribing information associated with thecanister that includes a recommendation to the medical practitioner toverify the compliance of a patient to an existing metered dose inhalermedication regimen prior to prescribing a different medication regimen.